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			Logo Research Brand Institute is the premier full-service branding agency dedicated to strategic and innovative brand naming and identity solutions. We strive to exceed the expectations of every client by combining leading-edge market research with the highest levels of client service, integrity and brand management Pexelizumab fails to meet primary endpoint with statistical significance; Alexion shares drop Shares of Alexion Pharmaceuticals Inc. dropped more than 27 percent after results from the company's Phase III PRIMO-CABG2 trial showed that its heart drug, pexelizumab, reduced the study's primary endpoint but did not reach the threshold of statistical significance. In the study of approximately 4,250 patients, the primary endpoint was the combined incidence of nonfatal myocardial infarction or death through 30 days after coronary artery bypass graft (CABG) surgery in patients with moderate to high risk. "We are clearly disappointed that pexelizumab did not meet its primary endpoint in PRIMO-CABG2. We look forward to completing an analysis of the data and obtaining a more in-depth understanding of these results," title="branding company" said Dr. Leonard Bell, chief executive officer of Alexion. Specifically, Alexion had hoped to have between 20 percent and 25 percent fewer MIs and deaths among patients taking pexelizumab as compared with those taking placebo, Bell said in a Dow Jones Newswires report. More detailed results of the trial, which was jointly sponsored by Alexion and Procter & Gamble Pharmaceuticals, are expected to be presented at an upcoming scientific meeting. Alexion said preliminary results indicate that the trial is "unlikely to support filing for licensing approval of pexelizumab in the CABG indication." title="branding company" Before these data were released, Banc of America Securities had projected that pexelizumab could have peak sales potential of $500 million per year, according to the Dow Jones Newswires report. Alexion is in the process of determining what potential implications these results may have on its Phase III APEX-AMI trial with pexelizumab. The study is designed to evaluate the benefits of pexelizumab in patients with MI who undergo primary percutaneous coronary intervention. More than 3,000 patients have been enrolled. The firm said it still expects results from the TRIUMPH Phase III trial with eculizumab in paroxysmal nocturnal hemoglobinuria to be available during the first quarter of next year. Alexion shares closed at $21.53, down $8.03, in heavy trading on the Nasdaq. Logo Research Beginning combination regimen with prednisone or Remicade possibly superior to sequential monotherapy, step-up combination One-year data from the BeSt trial show that an initial combination regimen that includes either prednisone or Centocor Inc.'s Remicade (infliximab) instead of sequential monotherapies or step-up combination therapies leads to earlier functional improvement and less radiographic damage in patients with early rheumatoid arthritis. In the trial, 508 adults with RA for two years or less were randomized to one of four treatment strategies. Medications were adjusted every three months, with the goal of obtaining a Disease Activity Score in 44 joints (DAS44) of 2.4 or less. Nearly three-fourths of the patients had erosive disease at baseline. Group one received sequential disease-modifying antirheumatic drug monotherapy (beginning with methotrexate and possibly changing to another monotherapy), representing conventional therapy in combination with tight disease control. Group two received step-up combination therapy (beginning with methotrexate and possibly adding sulfasalazine, hydroxychloroquine or prednisone). Patients in group three received combination treatment consisting of methotrexate, sulfasalazine and prednisone from the beginning. Group four received initial combination therapy with Remicade plus methotrexate, which was considered to be the most aggressive strategy. A greater proportion of patients in groups three and four (71 percent and 74 percent, respectively) than in groups one and two (53 percent and 64 percent) achieved a DAS44 of 2.4 or less after one year. Also, more patients in groups three and four compared with patients in groups one and two remained at the first stage of treatment because they sustained a DAS44 of 2.4 or less. Functional improvements, as measured by the average of the Dutch version of the Health Assessment Questionnaire (D-HAQ) scores, occurred more rapidly in patients who received initial combination therapy with prednisone or Remicade compared with sequential monotherapy or step-up combination treatment (groups one and two, mean D-HAQ score at three months, 1.0; groups three and four, mean D-HAQ score at three months, 0.6). Differences in D-HAQ scores between the treatment groups were smaller after one year but were still significant between group one and groups three or four. Furthermore, groups three and four had significantly less progression of radiographic joint damage than did groups one and two: median increases in total modified Sharp/Van der Heijde scores (SHS) were 2.0, 2.5, 1.0 and 0.5 for groups one through four, respectively. No progression of the total SHS occurred in 67 percent or more of the patients in each group. "[T]here is the possibility that effective suppression of disease activity during the early phases of the disease may ameliorate the long-term joint damage and poor physical function and, ideally, even induce true clinical remission without the need for disease-modifying antirheumatic drug treatment," title="branding company" the investigators postulated. Remicade is marketed by Centocor in the United States, while Schering-Plough Corp. markets it in other countries except in parts of Asia, where it is marketed by Tanabe Seiyaku Co. Ltd. or Xian-Janssen Pharmaceutical Ltd. The full study can be found in the November issue of the journal Arthritis & Rheumatism. Logo Research Adjunctive therapy with Keppra appears effective in refractory partial epilepsy UCB Pharma Inc.'s Keppra (levetiracetam) appears to be effective as adjunctive therapy in patients with treatment-refractory partial epilepsy, according to results of the SKATE trial. As part of an open-label, community-based study, 178 patients aged 16 years or older with refractory focal epilepsy were treated with Keppra 1,000 mg/day, 2,000 mg/d or 3,000 mg/d while maintaining stable doses of concomitant antiepileptic drugs (AEDs). The drug was initiated at a dose of 1,000 mg/d; this dosage was titrated during the first four weeks of treatment to a maximum dose of 3,000 mg/d. The primary outcomes of the study were the incidence of adverse events; the percent reductions in partial and total seizure frequency at the end of treatment as compared with baseline; and the retention rate, defined as the percentage of patients still taking Keppra at week 16. In general, median focal seizure frequency decreased by 47.6 percent during the 16-week treatment period. A similar decrease was observed for median total seizure frequency (46.5 percent). The responder rate, defined as the percentage of patients who achieved a reduction in seizure frequency of 50 percent or more, was 45.1 percent. Moreover, 16.6 percent of participants achieved seizure freedom during the study. A total of 151 patients completed 16 weeks of treatment, yielding a retention rate of 84.8 percent. Among 27 patients who withdrew prematurely, 17 withdrew because of adverse events and three withdrew because of a lack of efficacy. Approximately 61 percent of patients in the intent-to-treat population experienced at least one adverse event. The four serious adverse events considered possibly related to treatment with Keppra were a series of seizures with hospitalization, an episode of agitated depression with somatoform symptoms, a case of tremor and a case of psychosis. The study was published in the October issue of the journal Seizure. Logo Research Prescription drug rates are expected to rise at lower rate than health care costs, new data find Although health care and prescription drug costs may both continue to increase during the next year, pharmacy rate growth is expected to be lower than health care cost growth, according to new survey data. Consulting firm Aon Corp. polled more than 70 leading health care insurers for the survey. During the next 12 months, prescription drug costs are expected to increase by 11.8 percent, which is lower than the expected increases for HMOs (12.9 percent), POS plans and PPOs (13 percent for both) and consumer-driven health plans (13.3 percent). Last year, drug costs grew by 13.1 percent. The increase in the cost of specialty drugs, such as biotechnology-derived injectable drugs used to treat high-cost conditions, is anticipated to be a "significant" 19 percent during the next year. The data also showed that retirees may experience health care cost increases similar to those for active employees, due to the impact of the implementation of Medicare Part D prescription drug plans. Employers are likely to benefit from the subsidies offered through Medicare or lower premium rates in Medicare Advantage HMOs, but retirees will experience double-digit increases in medical costs, the study showed. Bill Sharon, Aon's senior vice president and director of the study, noted that the lower rates may be the result of various factors, including the successful implementation of three-tiered copayment plans that promote more generic drug use, as well as greater availability of generic or over-the-counter options and increased use of consumer-driven health care strategies. "The fact is that health care costs will continue to be the fastest growing expense for most companies," Sharon said. "As a result, initiatives such as consumer-driven health care, health promotion plans and disease management programs should all be viewed as viable options in managing health care costs." Logo Research Benefits of using fluoxetine to treat depressed pediatric patients outweigh potential risk of suicidal thoughts, attempts, according to report by task force The American College of Neuropsychopharmacology Task Force Report on SSRIs and Suicidal Behavior in Youth states that the benefits of treating depressed pediatric patients with fluoxetine outweigh the potential increase in the risk of suicidal ideation and nonfatal suicidal behavior. To conduct the evaluation, the ACNP Task Force reviewed published and unpublished data about the benefits and risks of selective serotonin reuptake inhibitors (SSRIs) and other new generation antidepressants for adults and children. The group found that, thus far, only fluoxetine has been documented to effectively treat depression in pediatric patients in two placebo-controlled clinical studies. No other SSRI, non-SSRI new generation antidepressant or tricyclic antidepressant has demonstrated effectiveness in this population. When the task force evaluated case reports of pediatric patients who became suicidal while taking SSRIs, it considered three possible explanations: SSRIs fail to relieve the suicidal behavior associated with depression because of a lag in antidepressant effect, an incomplete response or a treatment-resistant depression; SSRIs generate a new set of suicidal emotions or behaviors; SSRIs cause some patients to report on ideation or behavior that already exists or clinical improvement leads to action on existing suicidal feelings. The group said Food and Drug Administration meta-analyses of all randomized, controlled antidepressant trials in pediatric patients showed that suicidal ideation is not common and that suicide never occurred in the trials. However, a statistically significant two-fold risk of suicidal ideation or attempts occurred in the patients taking SSRIs for depression, according to the pooled adverse event reports (SSRIs, approximately 4 percent risk vs. placebo, 2 percent risk). "For individual drugs, this effect was highly variable and not statistically significant," title="branding company" the task force explained. Moreover, the FDA's analysis of systematic ratings of suicidal ideation and behavior in these antidepressant studies of depressed pediatric patients did not find a higher risk of worsened suicidal thoughts or behaviors among those taking SSRIs than among patients treated with placebo, "raising concerns over ascertainment artifacts in the AE report method," title="branding company" the ACNP added. The group also noted that other evidence, including epidemiology and autopsy studies, as well as recent cohort surveys, "do not support the hypothesis that SSRIs induce suicidal acts and suicide, instead indicating a possible beneficial effect, and that a negligible number of youth suicides are taking antidepressants at the time of death." title="branding company" The report actually found a substantial risk-benefit ratio for the use of fluoxetine in patients younger than 18. Using the FDA's meta-analyses of adverse event data and a very low threshold that included suicidal thoughts (not just suicide attempts) in the number needed to harm, the task force calculated that the average number needed to harm was 23 times the average number needed to treat (402 vs. 17.4, respectively). "Studies with larger samples, more statistical power and using systematic questionnaires to elicit safety data are needed to determine if the effect of antidepressants on suicidal ideation and nonlethal suicide attempts is real, and to try and determine the effect of antidepressants on risk of suicide in children and adolescents," title="branding company" the group suggested. Full results of the report were published online Nov. 23 in the journal Neuropsychopharmacology. Logo Research Some benefits of Arcoxia, naproxen therapy more pronounced in patients with ankylosing spondylitis without peripheral arthritis Although both nonsteroidal anti-inflammatory drugs and selective COX-2 inhibitors can effectively treat ankylosing spondylitis in patients with or without peripheral arthritis, relative treatment effects--including spinal improvement--seem to be more pronounced in patients who do not have a history of arthritis or chronic peripheral arthritis, according to a post hoc, subgroup analysis of a trial involving Merck & Co. Inc.'s Arcoxia (etoricoxib). During the six-week, double-blind trial, 387 patients with active axial ankylosing spondylitis were randomized to receive 90 mg or 120 mg of Arcoxia, 1,000 mg of naproxen or placebo each day. The randomization was stratified by the presence or absence of chronic peripheral arthritis. Ninety-three patients received placebo and 294 received either naproxen or Arcoxia. Chronic peripheral arthritis was defined as painful or swollen peripheral arthritis that had lasted for more than four weeks or a history of peripheral arthritis. In the analyses, which were based on the time-weighted average change from baseline for all observations across the six-week treatment period, data from the Arcoxia and naproxen arms were combined "to increase the sample size and precision for a subgroup analysis in patients with and without peripheral arthritis," title="branding company" the investigators explained. In patients with or without peripheral arthritis, the combined Arcoxia/naproxen group showed a statistically significant treatment response as compared with the placebo arm for all efficacy measures. However, the presence or absence of peripheral arthritis appeared to affect spinal pain and other endpoints, such as morning stiffness, patient assessments of peripheral pain and enthesopathy and response (as assessed by the Bath Ankylosing Spondylitis Disease Activity Index, visual analog scales and ASsessments in Ankylosing Spondylitis 20 criteria). Specifically, the difference in spinal pain response between the active-treatment and placebo groups was significantly greater in patients who did not have peripheral arthritis than in patients who did have peripheral arthritis (-32.5 mm vs. -17 mm, respectively). Although not significant, the other endpoints also demonstrated qualitatively similar differences. "The greater effects of treatment in patients without peripheral arthritis suggest that such patients may have different disease processes which are more NSAID-responsive than those in patients with peripheral arthritis," title="branding company" the researchers summarized. In October 2004, Merck received an approvable letter from the Food and Drug Administration regarding the use of Arcoxia in several inflammatory conditions. The firm is conducting further studies of the drug so it can provide additional efficacy and safety data requested by the regulatory agency. The study was published in the November issue of Annals of the Rheumatic Diseases. Logo Research Logo Research F. Hoffmann-La Roche Ltd. F. Hoffmann-La Roche Ltd. and Trimeris Inc. received an approvable letter from the Food and Drug Administration regarding the inclusion of information about the Biojector 2000 needle-free injection device in the labeling of Fuzeon (enfuvirtide), a drug used to treat HIV. Manufactured by Bioject Medical Technologies Inc., the Biojector 2000 is a carbon dioxide-powered injector that disperses a liquid drug beneath the skin. Roche and Trimeris filed a supplemental New Drug Application in May based on a study that compared the administration of Fuzeon using the Biojector 2000 versus a standard needle and syringe. Before deciding whether to approve the device, the FDA has requested additional information from the ongoing randomized, open-label WAND study, which is assessing tolerability of the device. Final data are expected in the second half of next year. Logo Research Logo Research Merck KGaA Merck KGaA's chief executive officer and chairman of the executive board, Dr. Bernhard Scheuble, resigned "with mutual agreement" and effective immediately after 24 years with the firm, according to a corporate press release. In a unanimous vote, Dr. Michael Roemer was named chairman of the executive board, also effective immediately. Roemer will maintain his responsibilities within the company's production, engineering, corporate purchasing, environmental issues and logistics sectors. Meanwhile, Elmar Schnee, who will for now continue to be responsible for the Merck's pharma ethicals division, will become a member of the board and take over Scheuble's position as head of the pharmaceutical business sector. Logo Research Logo Research UCB Group UCB Group plans to sell its UCB bioproducts division in a deal valued at approximately $117.9 million, Dutch newspaper De Tijd reported, according to PharmaTimes.com. The division's focus is on manufacturing peptides. Solvay SA, Akzo Nobel NV and Bachem Holding AG are potential buyers, PharmaTimes said. The Web site added that a recent report by consulting firm Frost & Sullivan ranks UCB as the second largest manufacturer of peptides in Europe, where the market for peptides is predicted to double in size by 2010 to $605 million. Logo Research Logo Research Neurobiological Technologies Inc. Neurobiological Technologies Inc. initiated the first of two double-blind, placebo-controlled Phase III trials during which a brief (no more than three hours) intravenous infusion of Viprinex (ancrod) will be administered to patients within six hours of the onset of acute ischemic stroke. The shorter, more intense treatment regimen is expected to benefit more patients and reduce the risk of symptomatic intracranial hemorrhage as compared with the five- to seven-day regimen used in previous studies. The primary endpoint of the first trial is the proportion of patients who are alive and can independently perform daily functions at 90 days as measured using the Barthel Index. The targeted number of patients to be enrolled in each of the trials is 650. Logo Research


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